Duns Number:035596579
Device Description: QB1 Post-Op Brace, NMES System; 2X-LARGE, REGULAR, RIGHT
Catalog Number
QB-1000-062
Brand Name
QB1 NMES System
Version/Model Number
QB-1000-062
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
feb5dade-8b64-452f-92a8-d27f3ad35c0a
Public Version Date
February 19, 2021
Public Version Number
6
DI Record Publish Date
May 04, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 90 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 91 |